The Illinois Workers' Compensation Commission has proposed new rules governing drug and alcohol testing to establish an employee's intoxication as a potential defense against liability. The rules establish detailed procedures for sample collection, testing, chain of custody documentation, and medical review that must be strictly followed. Non-compliance could result in test results being inadmissible. Most employers are advised to contract qualified third parties to conduct testing according to the rules rather than performing tests on-site. Comments on the proposed rules will be accepted until July 30, 2012.
Drug testing - against my human rights?Richard Evers
Is workplace drug testing against your human rights, or can HR or health and safety enforce a drug policy? What regulations apply and what is the actual process of drug testing?
The document outlines drug testing policies and procedures for pre-employment, random testing of employees required to have a commercial driver's license, reasonable suspicion testing, and outlines protections under the Americans with Disabilities Act. Employers are permitted to conduct drug testing if certain conditions are met to ensure a drug-free workplace while complying with state and federal regulations. The document provides guidance on testing procedures and appropriate responses to positive test results.
Handling Marijuana in Your Trucking Case - DRI April 2016 (00969830).PDFPatrick Foppe
The document discusses issues related to marijuana and truck drivers. It notes that marijuana is the second most prevalent psychoactive substance involved in driving under the influence cases. While some states have legalized medicinal or recreational use of marijuana, the Federal Motor Carrier Safety Administration and Department of Transportation take a zero tolerance approach and prohibit marijuana use for truck drivers subject to DOT regulations. The article provides an overview of drug testing requirements for truck drivers, including pre-employment, random, post-accident, and return-to-duty testing. It also discusses challenges for motor carriers and considerations for attorneys in handling marijuana issues that may arise in trucking accident cases.
FMCSA Drug and Alcohol Testing Program RegulationsScreensoft
The FMCSA drug and alcohol testing program regulations can be confusing and complex. So, we took our internal training presentation and decided to make it public. Use this to supplement the code of federal regulations (CFR) or for training your own staff. Content includes information from Title 49 Transportation CFR Part 40 and Part 382.
Here's what to expect:
-The DOT drug and alcohol testing procedures.
-The DOT drug and alcohol tests required for truck drivers.
-Visual aids including the post-accident drug and alcohol testing criteria.
-The random drug and alcohol testing requirements for truck drivers.
-The consequences for drug and alcohol use and violations.
-The requirements and procedures for the CDL drug and alcohol clearinghouse.
This document provides an overview of the Federal Motor Carrier Safety Administration's (FMCSA) alcohol and drug testing rules for commercial drivers. It summarizes the key aspects of the rules including: who is subject to testing, the types of tests required (pre-employment, post-accident, random, etc.), prohibited alcohol and drug conduct, testing procedures, consequences of violations, and record keeping and confidentiality requirements. The document is intended to provide a general summary and drivers and employers should refer to the full regulations for all legal requirements.
PHMSA Drug & Alcohol Testing Regulations [slide share]Screensoft
This presentation provides an overview of the DOT drug and alcohol testing regulations for employers in the oil and gas industry. It explains key aspects of establishing and managing a compliance program, including the roles of the DER, MRO, and SAP. It covers topics like the testing process, reasonable suspicion determinations, return-to-duty requirements, and random testing rate calculations. The goal is to help both new and experienced employers understand and properly implement the PHMSA regulations.
The document discusses drug testing in the workplace. It provides background on the rise of drug testing programs in American firms since the 1980s as a way to detect and address substance abuse issues. It then covers various aspects of drug testing including definitions of drugs, trends in drug testing, the perceived pros and cons of workplace drug testing programs, specifics of drug testing methods and what can be tested, factors that can impact drug test results, and common drug detection periods. It also briefly outlines drug testing practices by different industries.
Norton Medical Industries provides drug and alcohol testing services including sample collection, laboratory testing, medical review, and program management. They currently service El Paso's transit and parks departments. Samples would be collected via subcontracted collection sites and sent to MedTox laboratory for testing. The day-to-day program would be managed by Paula Rojas and Norton employs 15 people total to handle customer service and issues. Norton aims to provide responsive, high quality testing and support services to make the process easy for their clients.
Drug testing - against my human rights?Richard Evers
Is workplace drug testing against your human rights, or can HR or health and safety enforce a drug policy? What regulations apply and what is the actual process of drug testing?
The document outlines drug testing policies and procedures for pre-employment, random testing of employees required to have a commercial driver's license, reasonable suspicion testing, and outlines protections under the Americans with Disabilities Act. Employers are permitted to conduct drug testing if certain conditions are met to ensure a drug-free workplace while complying with state and federal regulations. The document provides guidance on testing procedures and appropriate responses to positive test results.
Handling Marijuana in Your Trucking Case - DRI April 2016 (00969830).PDFPatrick Foppe
The document discusses issues related to marijuana and truck drivers. It notes that marijuana is the second most prevalent psychoactive substance involved in driving under the influence cases. While some states have legalized medicinal or recreational use of marijuana, the Federal Motor Carrier Safety Administration and Department of Transportation take a zero tolerance approach and prohibit marijuana use for truck drivers subject to DOT regulations. The article provides an overview of drug testing requirements for truck drivers, including pre-employment, random, post-accident, and return-to-duty testing. It also discusses challenges for motor carriers and considerations for attorneys in handling marijuana issues that may arise in trucking accident cases.
FMCSA Drug and Alcohol Testing Program RegulationsScreensoft
The FMCSA drug and alcohol testing program regulations can be confusing and complex. So, we took our internal training presentation and decided to make it public. Use this to supplement the code of federal regulations (CFR) or for training your own staff. Content includes information from Title 49 Transportation CFR Part 40 and Part 382.
Here's what to expect:
-The DOT drug and alcohol testing procedures.
-The DOT drug and alcohol tests required for truck drivers.
-Visual aids including the post-accident drug and alcohol testing criteria.
-The random drug and alcohol testing requirements for truck drivers.
-The consequences for drug and alcohol use and violations.
-The requirements and procedures for the CDL drug and alcohol clearinghouse.
This document provides an overview of the Federal Motor Carrier Safety Administration's (FMCSA) alcohol and drug testing rules for commercial drivers. It summarizes the key aspects of the rules including: who is subject to testing, the types of tests required (pre-employment, post-accident, random, etc.), prohibited alcohol and drug conduct, testing procedures, consequences of violations, and record keeping and confidentiality requirements. The document is intended to provide a general summary and drivers and employers should refer to the full regulations for all legal requirements.
PHMSA Drug & Alcohol Testing Regulations [slide share]Screensoft
This presentation provides an overview of the DOT drug and alcohol testing regulations for employers in the oil and gas industry. It explains key aspects of establishing and managing a compliance program, including the roles of the DER, MRO, and SAP. It covers topics like the testing process, reasonable suspicion determinations, return-to-duty requirements, and random testing rate calculations. The goal is to help both new and experienced employers understand and properly implement the PHMSA regulations.
The document discusses drug testing in the workplace. It provides background on the rise of drug testing programs in American firms since the 1980s as a way to detect and address substance abuse issues. It then covers various aspects of drug testing including definitions of drugs, trends in drug testing, the perceived pros and cons of workplace drug testing programs, specifics of drug testing methods and what can be tested, factors that can impact drug test results, and common drug detection periods. It also briefly outlines drug testing practices by different industries.
Norton Medical Industries provides drug and alcohol testing services including sample collection, laboratory testing, medical review, and program management. They currently service El Paso's transit and parks departments. Samples would be collected via subcontracted collection sites and sent to MedTox laboratory for testing. The day-to-day program would be managed by Paula Rojas and Norton employs 15 people total to handle customer service and issues. Norton aims to provide responsive, high quality testing and support services to make the process easy for their clients.
This document discusses different types of drugs, their classification, effects, and factors related to drug abuse. It covers prescriptive and over-the-counter drugs, common drug administration routes, drug effects categories, legal drug categories, commonly abused drugs like narcotics, hallucinogens, and stimulants. The document also discusses factors that can lead to drug abuse like association, experimentation, habituation, and dependence. It outlines several groups of drug abusers and the general physical, psychological, social, mental, and economic effects of drug abuse.
Megan Kelly argues that some states do not require drug testing to receive welfare benefits but people need drug testing to work. Several states have proposed or passed legislation requiring drug testing for public assistance eligibility. Research shows that around 20% of welfare recipients report recent illicit drug use within the year, and drug and alcohol dependence is more common among women receiving welfare compared to other women. If the goal of welfare is promoting self-sufficiency, lawmakers argue that the first step should be stopping drug use that prevents recipients from entering the job market.
This document outlines various sections of The Dangerous Drugs Act of 2002 in the Philippines. It defines dangerous drugs and paraphernalia. It discusses penalties for various drug offenses which range from fines to life imprisonment. It also covers voluntary and compulsory treatment programs for drug dependence.
The Comprehensive Dangerous Drug Act of 2002 consolidates previous drug laws and outlines unlawful acts related to drug possession, sale, and trafficking. It establishes penalties such as life imprisonment or the death penalty depending on the drug and amount. The Act aims to prevent illegal drug use and addiction through prohibiting unlawful acts and enforcing penalties.
The document discusses the process of blood collection and preservation, including the roles and skills of phlebotomists, proper procedures for venous and capillary blood draws, handling and storage of blood samples, and potential issues that may occur during the blood collection process. It provides detailed guidance on selecting appropriate veins, preparing the patient, using the correct equipment and procedures, and storing blood samples to preserve their integrity for diagnostic testing.
The document discusses common laboratory procedures and related nursing responsibilities. It covers blood tests like complete blood counts and electrolyte panels. It also discusses urine tests, stool exams, sputum analysis, and various visualization procedures for the gastrointestinal and urinary systems. Nursing responsibilities include obtaining consent, preparing patients, collecting specimens, monitoring patients during tests, and following up after tests.
This document discusses drugs and their effects. It defines a drug as any chemical that affects the body's functioning. It notes that heroin, alcohol, ecstasy, caffeine and nicotine are all forms of drugs. Drugs must pass through the body and into the brain to change brain cell functioning by interfering with neurotransmitters. Drugs can make people less aware and alert, and can relieve pain, but can also cause sleepiness, convulsions, comas and even death. Hard drugs are physically addictive and easy to overdose on, while soft drugs are not physically addictive. Illegal drugs are classified as Class A, B or C depending on their penalties for possession and dealing. The document provides signs that someone
This document provides information about drugs and their effects. It defines drugs as substances that affect the body and brain, and notes that not all drugs are illegal. It then discusses different types of drugs like depressants, stimulants, and hallucinogens, providing examples of each and their effects. The document also addresses why people use drugs, signs of drug use, and what can be done to help someone with a drug problem.
This document talks about the new rule that was suggested by U.S. Department of Health and Human Sciences (HHS), with respect to sharing of lab test results with patients, as an amendment to Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.
The document discusses Florida laws and rules regarding optometric physicians. It provides information on the composition of the Florida Board of Optometry, their meeting dates and committee structure. It also summarizes the definitions of key terms in Florida law relating to optometry, such as licensed practitioner, certified optometrist, and rules around supervision. Finally, it discusses recent changes classifying optometrists as physicians by the Joint Commission.
The Labor Laws Compliance System (LLCS) refers to the integrated framework of voluntary compliance and enforcement of labor laws and social legislations issued pursuant to the rule-making, visitorial and enforcement power of the DOLE Secretary.
Supervisor Drug Awareness and Reasonable Suspicion by P&A Consulting ServicesAtlantic Training, LLC.
This document provides an overview of a supervisor drug awareness and reasonable suspicion training class. The objectives of the training are to educate supervisors on regulations regarding drug and alcohol testing, their roles and responsibilities, the costs of substance abuse, types of testing procedures, and how to determine reasonable suspicion. The training aims to teach supervisors how to identify and address issues related to drugs and alcohol in the workplace. It also covers how substance abuse affects businesses through increased costs. The training outlines federal DOT regulations for testing commercial drivers and testing procedures outlined in company policies. It provides facts on drug addiction and commonly abused substances, and gives examples of applying testing and policy rules in real workplace situations.
This document discusses Connecticut state law requirements regarding drug testing in the workplace. It notes that employees cannot be tested for drugs or alcohol without proper authorization. Pre-employment drug testing is allowed but prospective employees must be notified and given results. Random drug testing is only permitted for certain regulated industries or if an occupation has been designated as high-risk by the labor department. Employers can test employees involved in workplace accidents or if they have reasonable suspicion of drug use. The document provides an overview of the relevant state statutes and regulations regarding different types of drug testing that are permitted in Connecticut.
Company HSE for WC Welding Services 2014Chris Schmidt
The document is an occupational health and safety handbook for WC Welding Services Inc. that outlines the company's policies and procedures related to substance abuse, behavioral safety, personal protective equipment, emergency response, and various workplace hazards. It establishes a zero tolerance policy for drug and alcohol use. Employees must submit to drug screening and will be subject to disciplinary action or termination for a positive test. The handbook provides guidance on safety topics like lockout/tagout, electrical safety, fall protection, and confined space entry to help prevent injuries and protect worker health.
New flexible working regime in the United Kingdom Ius Laboris
The legal right to request flexible working arrangements in the UK was extended to all employees with 26 weeks of service starting June 30, 2014. Previously this right was restricted to employees with child or elder care responsibilities. Along with this change, the process for handling requests was replaced with a requirement for employers to deal with applications in a "reasonable manner" within three months. Employment tribunals must consider guidelines from ACAS, the UK conciliation service, when determining if an employer behaved reasonably. While the process changed, the reasons an employer can deny a request and penalties for improper handling remained the same.
The document discusses drug regulations and central testing laboratories in India. It provides information on the Central Drugs Standard Control Organization (CDSCO), which is responsible for regulating drugs in India. It oversees several laboratories across India that test drugs. The document also discusses ethics committees, new drug approvals, and the benefits of accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
This document discusses pre-employment background investigations that employers conduct, including drug/alcohol screening, criminal records checks, and other types of investigations. It notes that drug/alcohol screening is common and can be done through blood, urine, or hair tests, with urine being the most frequent method. Criminal records checks vary in scope from just the state to a full FBI records search, but employers must consider arrests separately from convictions due to bias. Overall, background checks aim to protect employers and customers but also require complying with laws around medical privacy and bias.
The document discusses important clauses that should be included in a clinical trial agreement (CTA). It outlines key provisions such as describing the clinical trial, the parties involved including sponsors, institutions, and principal investigators, governance and regulatory compliance, the obligations of each party, study conduct, monitoring, insurance, indemnification, terms and termination, governing law, and dispute resolution. The CTA is an essential legally binding document that regulates the relationship between the parties and addresses their rights and responsibilities regarding the clinical trial.
New Vaccination Rule: What Does it Mean for Employers with More Than 100 Empl...Parsons Behle & Latimer
This webinar discusses the new OSHA Emergency Temporary Standard (ETS) requiring employers with over 100 employees to implement mandatory vaccination policies or regular testing and masking. Key points include:
- The ETS takes effect November 5, 2021 and enforcement begins December 6, 2021.
- It applies to employers with 100+ employees but some employees may be excluded.
- Employers must establish and enforce a written vaccination policy or implement weekly testing and masking of unvaccinated employees. They must also provide paid time off for vaccination and recovery.
- Legal challenges have resulted in a stay of the enforcement by some courts while cases are reviewed. Employers are advised to prepare policies but wait for legal clarity.
The document summarizes key changes to NLRB election rules that accelerate the union election timeline. It discusses how petitions can now be served via email instead of fax. Employers will have only one business day to submit their position statement before a hearing, which is scheduled eight days after the petition. Employers must provide the voter list within two days of the election direction instead of seven. Objections to the election must be filed within seven days of the election. The document provides an example timeline showing how an election could occur as soon as two weeks after a petition is filed. It advises employers to prepare for the new rules by establishing rapid response teams and assessing employee data and policies.
This document discusses different types of drugs, their classification, effects, and factors related to drug abuse. It covers prescriptive and over-the-counter drugs, common drug administration routes, drug effects categories, legal drug categories, commonly abused drugs like narcotics, hallucinogens, and stimulants. The document also discusses factors that can lead to drug abuse like association, experimentation, habituation, and dependence. It outlines several groups of drug abusers and the general physical, psychological, social, mental, and economic effects of drug abuse.
Megan Kelly argues that some states do not require drug testing to receive welfare benefits but people need drug testing to work. Several states have proposed or passed legislation requiring drug testing for public assistance eligibility. Research shows that around 20% of welfare recipients report recent illicit drug use within the year, and drug and alcohol dependence is more common among women receiving welfare compared to other women. If the goal of welfare is promoting self-sufficiency, lawmakers argue that the first step should be stopping drug use that prevents recipients from entering the job market.
This document outlines various sections of The Dangerous Drugs Act of 2002 in the Philippines. It defines dangerous drugs and paraphernalia. It discusses penalties for various drug offenses which range from fines to life imprisonment. It also covers voluntary and compulsory treatment programs for drug dependence.
The Comprehensive Dangerous Drug Act of 2002 consolidates previous drug laws and outlines unlawful acts related to drug possession, sale, and trafficking. It establishes penalties such as life imprisonment or the death penalty depending on the drug and amount. The Act aims to prevent illegal drug use and addiction through prohibiting unlawful acts and enforcing penalties.
The document discusses the process of blood collection and preservation, including the roles and skills of phlebotomists, proper procedures for venous and capillary blood draws, handling and storage of blood samples, and potential issues that may occur during the blood collection process. It provides detailed guidance on selecting appropriate veins, preparing the patient, using the correct equipment and procedures, and storing blood samples to preserve their integrity for diagnostic testing.
The document discusses common laboratory procedures and related nursing responsibilities. It covers blood tests like complete blood counts and electrolyte panels. It also discusses urine tests, stool exams, sputum analysis, and various visualization procedures for the gastrointestinal and urinary systems. Nursing responsibilities include obtaining consent, preparing patients, collecting specimens, monitoring patients during tests, and following up after tests.
This document discusses drugs and their effects. It defines a drug as any chemical that affects the body's functioning. It notes that heroin, alcohol, ecstasy, caffeine and nicotine are all forms of drugs. Drugs must pass through the body and into the brain to change brain cell functioning by interfering with neurotransmitters. Drugs can make people less aware and alert, and can relieve pain, but can also cause sleepiness, convulsions, comas and even death. Hard drugs are physically addictive and easy to overdose on, while soft drugs are not physically addictive. Illegal drugs are classified as Class A, B or C depending on their penalties for possession and dealing. The document provides signs that someone
This document provides information about drugs and their effects. It defines drugs as substances that affect the body and brain, and notes that not all drugs are illegal. It then discusses different types of drugs like depressants, stimulants, and hallucinogens, providing examples of each and their effects. The document also addresses why people use drugs, signs of drug use, and what can be done to help someone with a drug problem.
This document talks about the new rule that was suggested by U.S. Department of Health and Human Sciences (HHS), with respect to sharing of lab test results with patients, as an amendment to Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.
The document discusses Florida laws and rules regarding optometric physicians. It provides information on the composition of the Florida Board of Optometry, their meeting dates and committee structure. It also summarizes the definitions of key terms in Florida law relating to optometry, such as licensed practitioner, certified optometrist, and rules around supervision. Finally, it discusses recent changes classifying optometrists as physicians by the Joint Commission.
The Labor Laws Compliance System (LLCS) refers to the integrated framework of voluntary compliance and enforcement of labor laws and social legislations issued pursuant to the rule-making, visitorial and enforcement power of the DOLE Secretary.
Supervisor Drug Awareness and Reasonable Suspicion by P&A Consulting ServicesAtlantic Training, LLC.
This document provides an overview of a supervisor drug awareness and reasonable suspicion training class. The objectives of the training are to educate supervisors on regulations regarding drug and alcohol testing, their roles and responsibilities, the costs of substance abuse, types of testing procedures, and how to determine reasonable suspicion. The training aims to teach supervisors how to identify and address issues related to drugs and alcohol in the workplace. It also covers how substance abuse affects businesses through increased costs. The training outlines federal DOT regulations for testing commercial drivers and testing procedures outlined in company policies. It provides facts on drug addiction and commonly abused substances, and gives examples of applying testing and policy rules in real workplace situations.
This document discusses Connecticut state law requirements regarding drug testing in the workplace. It notes that employees cannot be tested for drugs or alcohol without proper authorization. Pre-employment drug testing is allowed but prospective employees must be notified and given results. Random drug testing is only permitted for certain regulated industries or if an occupation has been designated as high-risk by the labor department. Employers can test employees involved in workplace accidents or if they have reasonable suspicion of drug use. The document provides an overview of the relevant state statutes and regulations regarding different types of drug testing that are permitted in Connecticut.
Company HSE for WC Welding Services 2014Chris Schmidt
The document is an occupational health and safety handbook for WC Welding Services Inc. that outlines the company's policies and procedures related to substance abuse, behavioral safety, personal protective equipment, emergency response, and various workplace hazards. It establishes a zero tolerance policy for drug and alcohol use. Employees must submit to drug screening and will be subject to disciplinary action or termination for a positive test. The handbook provides guidance on safety topics like lockout/tagout, electrical safety, fall protection, and confined space entry to help prevent injuries and protect worker health.
New flexible working regime in the United Kingdom Ius Laboris
The legal right to request flexible working arrangements in the UK was extended to all employees with 26 weeks of service starting June 30, 2014. Previously this right was restricted to employees with child or elder care responsibilities. Along with this change, the process for handling requests was replaced with a requirement for employers to deal with applications in a "reasonable manner" within three months. Employment tribunals must consider guidelines from ACAS, the UK conciliation service, when determining if an employer behaved reasonably. While the process changed, the reasons an employer can deny a request and penalties for improper handling remained the same.
The document discusses drug regulations and central testing laboratories in India. It provides information on the Central Drugs Standard Control Organization (CDSCO), which is responsible for regulating drugs in India. It oversees several laboratories across India that test drugs. The document also discusses ethics committees, new drug approvals, and the benefits of accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
This document discusses pre-employment background investigations that employers conduct, including drug/alcohol screening, criminal records checks, and other types of investigations. It notes that drug/alcohol screening is common and can be done through blood, urine, or hair tests, with urine being the most frequent method. Criminal records checks vary in scope from just the state to a full FBI records search, but employers must consider arrests separately from convictions due to bias. Overall, background checks aim to protect employers and customers but also require complying with laws around medical privacy and bias.
The document discusses important clauses that should be included in a clinical trial agreement (CTA). It outlines key provisions such as describing the clinical trial, the parties involved including sponsors, institutions, and principal investigators, governance and regulatory compliance, the obligations of each party, study conduct, monitoring, insurance, indemnification, terms and termination, governing law, and dispute resolution. The CTA is an essential legally binding document that regulates the relationship between the parties and addresses their rights and responsibilities regarding the clinical trial.
New Vaccination Rule: What Does it Mean for Employers with More Than 100 Empl...Parsons Behle & Latimer
This webinar discusses the new OSHA Emergency Temporary Standard (ETS) requiring employers with over 100 employees to implement mandatory vaccination policies or regular testing and masking. Key points include:
- The ETS takes effect November 5, 2021 and enforcement begins December 6, 2021.
- It applies to employers with 100+ employees but some employees may be excluded.
- Employers must establish and enforce a written vaccination policy or implement weekly testing and masking of unvaccinated employees. They must also provide paid time off for vaccination and recovery.
- Legal challenges have resulted in a stay of the enforcement by some courts while cases are reviewed. Employers are advised to prepare policies but wait for legal clarity.
The document summarizes key changes to NLRB election rules that accelerate the union election timeline. It discusses how petitions can now be served via email instead of fax. Employers will have only one business day to submit their position statement before a hearing, which is scheduled eight days after the petition. Employers must provide the voter list within two days of the election direction instead of seven. Objections to the election must be filed within seven days of the election. The document provides an example timeline showing how an election could occur as soon as two weeks after a petition is filed. It advises employers to prepare for the new rules by establishing rapid response teams and assessing employee data and policies.
HR in Pharma Networking Event - Fiona Coombe CK Group
The document discusses quality standards in recruitment in the UK. It provides information on REC, the largest trade association representing the private recruitment industry. REC members must sign a code of practice and ethics and can be subject to inspections. The document also outlines various laws regarding employment agencies, standards for recruiters, and recent regulations such as the Agency Workers Regulations.
This document outlines 10 key regulatory requirements for conducting clinical trials in India. It defines what constitutes a new drug and clinical trial. It discusses the need for ethics committee approval and registration, informed consent, reporting of adverse events, and compensation for injuries. The document emphasizes that clinical sites must be prepared for inspection and certain non-drug intervention studies still require ethics approval and registration. Overall, it provides an overview of the regulatory framework and responsibilities for investigators conducting clinical research in India.
The document provides an overview of clinical trial statistics and regulatory updates from India. It discusses the increasing number of registered ethics committees in India and importance of quality and compliance. The newsletter also highlights key metrics sites should focus on to improve performance and notes recent Indian regulatory milestones related to clinical trials. Additionally, it briefly summarizes an FDA approval of a new drug and a platform aiming to improve patient recruitment for clinical trials.
The medical associations and specialty societies writing this letter have serious concerns about the implementation of the Physician Payments Sunshine Act. Specifically:
1) CMS has proposed changing the reporting exclusion for continuing medical education activities in a way that could significantly and negatively impact CME. The organizations recommend a slight modification to the proposal.
2) CMS's interpretation of the educational materials exclusion is too narrow and should be reconsidered to include medical textbooks and journal articles that directly benefit patients.
3) The condensed timeframe for physician registration does not allow adequate time for registration or review/dispute of reports before publication. The organizations strongly urge postponing publication for six months.
4) The registration process is overly complex
New drugs and clinical trial rules 2019.pdfcrazyboy92
The document summarizes key highlights of the New Drugs and Clinical Trial Rules, 2019 in India. Some of the major changes include defined timelines for approval of clinical trial applications, increased application fees, changes to ethics committee composition and registration validity. It also outlines new definitions, documentation requirements, and provisions for post-trial access and academic clinical trials. The rules supersede the existing Drugs and Cosmetics Rules and aim to encourage new drug development in India while strengthening the clinical trial approval process.
The NLRB implemented new expedited election rules in 2015 that significantly shorten the timeline for union representation elections. The new rules reduce the period between a union petition and election from an average of 38 days to as few as 11 days. This accelerated process strongly benefits unions by limiting the time employers have to communicate with employees about why they should vote against unionization. The expedited rules encompass many procedural changes that give regional directors more discretion and make it harder for employers to litigate issues or seek review of pre-election rulings. Overall, the new rules pave the way for what are being called "ambush elections" that make it much more difficult for employers to respond to union organizing efforts.
1. Monday, July 23, 2012 3:02 PM
Subject: IWCC Proposed Rules For Drug Testing
Date: Monday, July 23, 2012 2:31 PM Jul 23
From: Joe Garofalo <jgarofalo@gshslaw.com>
To: bhart@gshslaw.com
Conversation: IWCC Proposed Rules For Drug Testing
Dear Friends,
The Illinois Workers' Compensation Commission has finally published a proposed Rule governing the
collection and testing of samples for alcohol and other drugs that may form the basis for an employer’s
defense to a claim for workers’ compensation benefits due to an employee’s intoxication. The Commission
will be taking comments on this proposed Rule through July 30, 2012.
Matt Novak has prepared a wonderful synopsis of the proposed Rule which is contained below. As you will
see from his article, strict compliance with the Rule will be necessary in order to introduce the results of
alcohol and drug testing into evidence. In light of the onerous requirements to admit such evidence we
recommend that most employers NOT engage in the alcohol and drug collection process themselves but
instead contract with outside firms who are already engaged in this process as their main business and who
are in compliance with these requirements. For those employers who are already performing such testing and
intend to continue to do so on site, please note that it will be essential to comply with the rules for collection
or testing or else the test results will not be admissible in evidence.
Please feel free to contact us with any questions or comments you may have regarding this matter.
Sincerely yours,
Joe Garofalo
COMMISSION PROPOSES RULES FOR DRUG TESTING
As many of our readers may know, the most recent amendments to the Illinois Workers’ Compensation Act amend Section
11 to establish an employee’s intoxication as a potential defense against liability for injuries sustained in a work accident.
This amendment, which became effective June 28, 2011, charged the Illinois Workers’ Compensation Commission (the
“Commission”) with developing rules for sample collection and testing for alcohol and other drugs that could be considered
intoxicating substances. On June 15, 2012 the Commission published its proposed rules governing the collection and
testing of samples for alcohol and other drugs. Please note that there is a comment period during which time interested
parties can provide their thoughts or opinions on the proposed rules, which closes forty-five days after the date of
publication, or July 30, 2012. Interested parties should contact Kimberly B. Janas, the Secretary of the Commission, with
their comments before the close of time period. Her information is as follows:
Illinois Workers’ Compensation Commission
100 West Randolph Street, Suite 8-200
Chicago, Illinois 60601
PH: (312) 814-6559
FAX: (312) 814-3520
k.janas@illinois.gov
Page 1 of 4
2. k.janas@illinois.gov
The proposed rules are thirty-one pages in length, and cover in detail the process and procedure of collecting different
types of specimens and conducting tests to establish intoxication by alcohol or other substances. What follows is a brief
summary of the proposed rules and some of the possible ways it may affect administering and defending workers’
compensation claims in Illinois.
CHAIN OF CUSTODY FORM
After a section outlining the definitions of various terms used in the proposed rules, Proposed Rule 9140.10 creates a
“Chain of Custody Form” to be used in the collection of blood and urine specimens. It is not indicated whether the
Commission will publish this Chain of Custody Form, or if employers, insurance carriers or medical providers will need to
develop and publish their own forms independently. This rule indicates the Chain of Custody Form must have four
sections, with each section having specific informational requirements to be completed by the various parties participating
in the specimen collection and testing process. The rule also provides that there needs to be seven copies of the Form,
and that the parties involved in the collection and testing process must keep a copy of the Form for a minimum of two
years. The rule specifically states that the Chain of Custody Form must include all of the information specified within the
rule. This is a mandatory requirement, and the use of any non-complying form, or the failure of a party to properly complete
a form, could result in the test results being excluded from evidence at trial. While the use of a non-complying Form should
not be an issue of the Commission creates and provides a Chain of Custody Form for parties to utilize, the use of a privately
created form could cause issues by failing to comply with the rule.
COLLECTION OF BLOOD AND URINE SAMPLES
Proposed Rules 9140.20 and 9140.30 govern the collection procedures for specimens of blood and urine, respectively.
Only certain medical personnel, such as a licensed physician or a registered nurse, are allowed perform the collection of
blood specimens under the rules. Urine collection can be done not only by certain medical personnel, but also by a person
meeting the training requirements of United States Department of Transportation’s training requirements as specified in the
Code of Federal Regulations (49 CFR 40.33). It is conceivable that an employee of the employer could meet these training
requirements and serve as a urine collector, and the rules contemplate this possibility by specifically excluding an
employee’s immediate supervisor from being the collector, unless no other collector is available. The Rules establishing the
process for collecting urine specimens are so lengthy and detailed, taking up over six pages or the rules themselves, that
we believe it highly impractical for an employer to conduct urine collections onsite and with its own employees. Rather, we
believe employers would be best served having a designated clinic or other facility conduct its both blood and urine
collections, provided those facilities conform to the Commission’s rules. Otherwise, any failure to follow the requirements of
the rules in the collection process may render a positive drug test result inadmissible, making an intoxication defense
impossible.
MEDICAL REVIEW OFFICERS
Rule 9140.40 creates the process of review and verification of test results by a medical review officer (MRO). An MRO is
defined as the person meeting the qualifications set forth in the Code of Federal Regulations, 49 CFR 40.121, and cannot
be employed by the laboratory performing the testing of the relevant samples. Furthermore, an employer or a designated
employer representative cannot serve as the MRO for his or her own employees. All test results must be sent from the
laboratory to an MRO to be reviewed and verified. When the MRO receives a positive, adulterated or a substituted result
from the laboratory, the MRO is required to contact the employee within seventy-two hours of receiving the test result. The
purpose of contacting the employee is to create an opportunity for the employee to provide information that the he or she
considers relevant to explain a positive, substituted or adulterated test result. For example, an employee may identify for
the MRO the use of certain prescription or non-prescription medications that could have influenced the test result. If the
MRO is unable to contact the employee to discuss the positive, adulterated or substituted test results, it becomes the duty
of the designated employer representative to contact the employee to have him or her contact the MRI as soon as
possible. There is no information provided as to what happens if the employee fails to contact the MRO altogether, but it
would appear that the MRO is free to verify the test results without input from the employee, and to transmit that evidence to
the employer or the designated employer representative after the seventy-two hour contact period has lapsed.
The MRO is charged with taking various steps to verify the testing results, taking particular care when the lab reports a
positive, adulterated or substituted test result. The MRO is also charged with verifying and forwarding negative test results
to the parties.
SPLIT TESTING OF URINE AND BLOOD SPECIMENS
Proposed Rule 9140.50 sets up the procedures for split testing. When an employee has a positive, adulterated or
substituted result from the laboratory, he or she may provide a written or verbal request to the MRO to have a split
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3. substituted result from the laboratory, he or she may provide a written or verbal request to the MRO to have a split
specimen undergo testing procedures. The rule states that this request must be provided within seventy-two hours or
receiving notification of a positive, adulterated or substituted test result from the MRO, unless the employee can provide a
legitimate reason for his or her failure to contact the MRO within seventy-two hours.
The rule specifically states that the employer shall ensure the split specimen testing is conducted as required, which we
take to mean the employer must guaranty payment to the second laboratory for the cost of testing the split specimen. An
employer may, however, seek repayment or reimbursement of all or part of the cost of the split specimen testing from the
employee, though an employer cannot condition performance of the split testing upon he employee’s payment of the costs
associated with the test. In the likely event that an employee refuses to pay or reimburse the employer for the costs of split
testing, perhaps the employer could claim a credit to offset the payment of benefits in an amount equal to the cost of split
testing, should the case proceed to trial.
COLLECTION AND TESTING OF BREATH AND SALIVA FOR ALCOHOL TESTING
Rule 9140.60 outlines the process of procedures of conducting testing for alcohol through both breath and saliva. The rule
states that collectors for alcohol testing must meet the training requirements set forth in 49 CFR 40.213. Again, these rules
contemplate that an employee of the employer could serve as a collector for alcohol testing.
It is important to note that any collection method used by law enforcement officers is to be considered acceptable procedure
for the collection of testing of breath and alcohol under these other proposed rules. It does state that any collection of
breath or testing or performed by a law enforcement officer is subject to any objection pursuant to the Illinois Rules of
Evidence and statutory rules of evidence where applicable.
Alcohol testing must also be documented using a collection form, different than the Chain of Custody Form, and the rules
specify what information must be documented in the collection form. Similar to other collection methods, the collection
procedures for breath and saliva when testing for alcohol are specific and detailed, and the rules state that all of the
process and procedures must be complied with. Beyond having to obtain and maintain conforming testing equipment, the
testing technician must ensure that each test is conducted in accordance with the specific procedure outlined by the rules.
Therefore, unless an employer has unique or extenuating circumstances requiring immediate onsite testing, we would not
recommend an employer take upon itself the job of conducting breath or saliva testing of its employees for alcohol. We
believe it would be better to allocate the testing process to professionals who conduct this testing process on a regular
basis to ensure that all the requirements of the rules are met, and to ensure that the positive test result is admissible at
hearing. Should an employer decide to engage in alcohol testing through breath or saliva analysis, careful review of the
referenced Code of Federal Regulations, as well as the Commission Rules, will be necessary in order to ensure compliance
with the testing procedures used.
PRESERVATION OF SPECIMENS AND RECORDS
Proposed Rule 9140.70 specifies the length of time the parties must keep either specimens or records associated with drug
testing. Laboratories testing the primary specimen of blood or urine with appositive, adulterated or substantive result must
retain the specimen for a minimum of three years, and it must be stored in a manner as outlined in the rules and in
accordance with the requirements set forth by the Department of Health and Human Services (though not specified, it
appears the rule is referring to the Federal agency). An employee, the MRO, or the employer may request, in writing, that
the laboratory retain a specimen for an additional period of time not to exceed one year. Split specimens must also be
retained in a similar fashion. Laboratories must retain all records pertaining to the testing of each employee specimen for a
minimum of two years, though this can be extended through a written request for an additional two years. Employers are
required to maintain all collection forms for breath and saliva testing for a minimum of three years, and the employee may
request an extension of up to an additional year. Negative testing samples are to be discarded as soon as possible.
CONCLUSION
Many employers conduct routine drug testing anytime an employee reports a workers’ compensation injury. For those
employers, we recommend confirming with your drug testing vendors to confirm whether the procedures to have in place
will comply with proposed rules to ensure a timely and effective transition for defending injuries resulting from alcohol or
drug intoxication. As it seems that the Commission borrowed from the Code of Federal Regulations when drafting these
proposed rules on the process and procedure of specimen collection and drug testing, it is possible that most facilities
currently providing specimen collection or drug testing will already be in compliance with these proposed rules.
Nevertheless, any facility must be prepared to confirm that it wholly complies with the proposed rules, as even substantial
compliance with the rules may still result in a positive drug test result being barred from evidence. This is due to the fact
that the rules use mandatory terms like “shall” and “must” throughout.
For those employers who do not perform routine drug testing at the time an accident is reported, we would recommend
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4. For those employers who do not perform routine drug testing at the time an accident is reported, we would recommend
identifying a facility or vendor that complies with the proposed rules to which an employee suspected of intoxication can be
referred for appropriate sample collection and testing. Even if it is clear by circumstantial evidence that an employee’s
accident was caused by his or her intoxication, a failure to properly preserve this evidence through a conforming collection
and testing process could result in an inability to deny the claim. By having an appropriate facility identified in advance, the
chances of successfully obtaining an admissible test result and defending a claim could increase significantly.
Should you have any questions or concerns regarding these proposed comments, please feel free to contact any of the
attorneys in our office to discuss them in greater detail. We look forward to an open ongoing dialog with our clients as this
new statutory defense in intoxication continues to develop.
--
Joseph A. Garofalo
Garofalo, Schreiber, Hart & Storm, Chartered
55 West Wacker Drive, 10th Floor
Chicago, IL 60601
Office: 312-670-2000
Direct: 312-499-8911
Cell: 312-622-3750
Fax: 312-419-1336
jgarofalo@gshslaw.com
www.gshslaw.com
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